LEVEL 1 GENERAL PURPOSE PROBE
Received Mar 30, 2026 · Event occurred Sep 1, 2024
Report 3012307300-2026-03034 · MDR key 24729115
Device
Generic name
Thermometer, Electronic, Clinical
Manufacturer
Icu Healthcare Manufacturing S.a. De C.v.Catalog number
ER400-9
Lot number
4448623
Product problems
- Device Displays Incorrect Message
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS FILE WAS ORIGINALLY INCORRECTLY FILED UNDER REGISTRATION NUMBER MRN 9617604-2024-00764. THE DATE OF THAT SUBMISSION WAS (DATE) (TIME STAMP IS NOT NECESSARY) 27-SEP-2024 DEVICE EVALUATION: THERE WAS ONE DEVICE RECEIVED FOR DEVICE ANALYSIS. SERVICE HISTORY REVIEW IDENTIFIED THE COMPLAINT WAS NOT RELATED TO A PREVIOUS SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. FUNCTIONAL TESTING AND VISUAL INSPECTION PERFORMED DURING ANALYSIS. THE CUSTOMER REPORTED COMPLAINT COULD NOT BE DUPLICATED OR CONFIRMED. THE PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THERE WAS A SENSE OF DISCOMFORT IN THE TOUCH OF THE PROBE AS USUAL, AND THE TEMPERATURE WAS DISPLAYED SLIGHTLY LOWER THAN USUAL. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.